
Hamzah Bahmudah
Validation & Calibration Pharmacist

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About me
Capital Investment Lead at Bayer
Education

Universitas Airlangga
2004 - 2008Bachelor of Pharmacy (B.Pharm.) Pharmacy 3.20
Universitas Airlangga
2008 - 2009Apothecary (Apt.) Industrial Pharmacy 3.55
Experience
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Landson PT Pertiwi Agung (a member of Mensa Group)
May 2010 - Jun 2011Validation & Calibration PharmacistDevelop process validation, analytical method validation, calibration and qualification program.Handling calibration for instruments in QC and R&D Laboratorium and machines in Production Area.Execute internal and external process validation.Supervise of three analyst for analytical method validation.Handling qualification (installation, operational, and performance) with engineering department.Acting Assistant Manager Quality Assurance (Handling deviation, change control, review batch record, pest control, internal and external audit). Show less

SOHO Global Health
Jun 2011 - Jul 2013Develop analytical method validation and calibration program.Document and review internal and external calibration certificate and ensure all instrument in Manufacturing Division is properly calibrated.Control and responsible for budgeting, purchasing, calibration, trouble shooting and preventive maintenance instrument at Quality Operation Division. Investigate calibration result which deviate from establish standard.Prepare, maintain and review analytical method validation and compliance documentation, such as proforma, training records, chromatogram/ spectrogram, etc.Develop, integrate and revise Standard Operating Procedure (SOP) for instrument and support facilities at Quality Operation Division.Support all systems are running according to necessary specifications and operate within regulations to ensure the production of quality products.Any other related duties as assigned by Quality Assurance Dept Head. Show less
Quality Support Section Head
Aug 2011 - Jul 2013Instrument & Calibration Section Head
Jun 2011 - Aug 2011

GSK
Jul 2013 - Dec 2019Continue to lead the site Technical Department as a key member of the Site Leadership Team, manage 3 sub department team (NPI, Manufacturing, & Packaging).Provide technical support to the Commercial and Category teams to ensure smooth delivery of new products to the market and expansion of the existing product portfolio : Scalable M-ERPs, Artwork Management System Harmony, Halal Audit and Product Certifications, Asia Strategic Network Topical & Liquid Project (Triaminic & Voltaren Emulgel Transfer Product), Solid Upgrade ImprovementDeliver new product at site On Time In Full (OTIF)Lead implementation Product Life-cycle Management (PLM) Show less Lead the site Technical Department as a key member of the Site Leadership Team with focus on performance, delivery, capability, behavioral development and talent managementProvide technical support to the Commercial and Category teams to ensure smooth delivery of new products to the market and expansion of the existing product portfolio : Vates Portfolio, Zovirax Localization, CRSF Program, MDI Project, Wellness Expansion Project, JV GSK – Novartis IntegrationFully implement TRA, PCS and PPA program across all products; Continued Product Lifecycle Management deployment for all NPIs, Process Robustness interventions and new technologiesEnsure that Site Safety & Quality Compliance is championed as part of Leadership team Show less
Site Technical Lead
Oct 2016 - Dec 2019Acting Site Technical Lead
Mar 2015 - Oct 2016Manufacturing Technologist
Jul 2013 - Mar 2015

Bayer
Feb 2020 - nowLead planning, scheduling, execution, monitoring, and documenting all Capital Expenditure (CapEx) Investment project activities, both new and replacement Technical System, up to the handover process Technical System users in accordance with Bayer Regulations, including develop, implement, and control all project scopes up to completion of commissioning and qualification activities. Control the achievement of the project through setting schedules and budgets, including forecasting, for all Single Budget projects under responsibility Site Engineering is responsible and reports this matter through the Project Steering Committee Meeting. Show less Responsible for reformulation & improvement project of existing UIs/SKUs, from planning, budgeting and execution of the projectPlanning and involved in execution in packaging development project including harmonization, new or alternative packaging materials related with NPD, improvement and sustainability Managing development process executed in timely manner according to project timeline using Quality by Design concept & close coordination with technical project leadsResponsible for efficiency or cost-saving for improvement projects Show less
Capital Investment Lead
Aug 2024 - nowCapital Investment & Infrastructure Manager
Mar 2024 - Mar 2025Engineering Project Manager
Nov 2022 - Mar 2024Technical Support Manager
Feb 2022 - Dec 2022Global Category Project Manager, Nutritionals & Digestive Health
Jul 2021 - Feb 2022New Product Development & Technical Innovation Manager
Feb 2020 - Feb 2022
Licenses & Certifications
- View certificate

Excel: VLOOKUP and XLOOKUP for Beginners
LinkedInAug 2021
Languages
- enEnglish
- inIndonesian
- jaJavanese
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